SOURCE: The Law Offices of Shawn Khorrami

March 28, 2007 18:02 ET

Attorney Shawn Khorrami Releases Commentary in Response to Government Inquiries Into Off-Label Drug Use Marketing by Pharmaceutical Companies

LOS ANGELES, CA -- (MARKET WIRE) -- March 28, 2007 -- With the U.S. Justice Department issuing three subpoenas to Johnson & Johnson this month and the The House Committee on Oversight and Government Reform requesting marketing documents from two stent and three drug manufacturers, it is clear that the ongoing investigations over drug company promotion of off-label prescriptions are heating up.

Off-label prescriptions -- the practice of prescribing pharmaceutical drugs for a medical condition outside the scope of the drug's FDA-approved ailment -- are legal and common. Drug company promotion of the off-label use of drugs is illegal, however.

In light of recent developments, Attorney Shawn Khorrami in Los Angeles contends that drug companies have become well-versed in deploying subtle strategies to bolster their sales of drugs for "off-label" uses, thus increasing risks to consumers. While some off-label prescriptions can be valuable, a number have proved harmful, even deadly.

Khorrami carries one of the largest pharmaceutical case loads in the country, including cases against the makers of Vioxx and Fosamax (Merck), Ortho Evra Patch (Johnson & Johnson), Prempro (Wyeth Pharmaceuticals), Celebrex and Bextra (Pfizer), Zyprexa (Eli Lilly), ReNu (Bausch & Lomb) and a number of others.

One common marketing approach among drug companies is to simply "tell" doctors about the use of a drug for conditions not approved by the FDA, including alteration of dosage and duration. Claiming First Amendment protection, "anecdotal" marketing of off-label usage has been controversial for many years.

More insidious marketing practices, however, are also common in Khorrami's opinion. While pharmaceutical companies are legally prohibited from promoting off-label usage of drugs, physicians have no such restrictions, and many are in essence becoming drug reps for pharmaceutical companies through nonprofit and educational institutions as well as financially driven independent organizations. Such organizations have received great contributions from drug companies.

Khorrami further feels that drug companies essentially "ghostwrite" editorials and other scientific statements on off-label drug use for medical experts that they basically hire. They also work the same way with nonprofits to which they donate money. The drug companies then distribute this content to other practicing physicians. Sometimes companies recruit doctors into their paid speakers bureaus to "discuss" off-label use of drugs. Oftentimes these recommendations get adopted by practicing physicians and the unapproved use of off-label drugs becomes widespread.

Off-label drug prescriptions are said to make up about 20%-60% of the nations annual prescription drug bill by pharmaceutical companies including GlaxoSmithKline, Pfizer, and Wyeth.

By law, doctors need not notify patients that a drug has been prescribed off-label. Khorrami suggests that consumers protect themselves by asking doctors the following questions:

--  Has the FDA approved this medication for my specific ailment?
--  Has the specific dosage and duration also been approved?
--  What information was drawn on to conclude that this prescription is
    right for me?
--  What are the benefits and risks to a particular off-label
    prescription, and how can they be verified without FDA approval?
--  Are their alternate FDA approved treatments for my condition?
    

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